INTRAFIX 254670Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705013524), received between Jan 30, 2019 and Jun 7, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Crack; Crack

  THIS IS REPORT 4 OF 7 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT TWO OF THE FEMORAL INTRAFIX SHEATH TRIAL, 8MM - 8.5MM, TWO OF THE FEMORAL INTRAFIX SHEATH INSERTER, 8MM - 8.5MM, ONE FEMORAL INTRAFIX SHEATH TRIAL, 9MM - 10MM, ONE FEMORAL INTRAFIX SHEATH INSERTER, 9MM - 10MM AND ONE ACL TIE TENSIONER WERE FOUND CRACKED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626636 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT THE FEMORAL INTRAFX SHTH INS9&10MM HANDLE BROKE WHEN REVERSE MALLET. THE PROCEDURE WAS COMPLETED WITHOUT DELAY REPORTED. THIS DEVICE HAS BEEN DISCARDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252242 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED VIA PHONE THAT THE CUSTOMER'S INTRAFIX FEMORAL SHEATH INSERTER 9/10MM HANDLE SPLIT IN HALF DURING AN ACL PROCEDURE. WHERE THE DEVICE BROKE STAYS OUTSIDE THE PATIENT AND CONFIRMED NO DEBRIS FELL IN THE PATIENT. THE CASE WAS COMPLETED USING THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289059 ↗